Overview

This trial has been completed.

Condition pi3k pathway activated tumors
Treatment bkm120
Phase phase 2
Target PI3K
Sponsor Novartis Pharmaceuticals
Start date March 2013
End date September 2016
Trial size 145 participants
Trial identifier NCT01833169, CBKM120ZUS40

Summary

The purpose of this signal seeking study is to determine whether treatment with BKM120 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
BKM120 100 mg (oral gelatine capsules) will be administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
bkm120
BKM120 100 mg (oral gelatine capsules) will be administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle

Primary Outcomes

Measure
Rate of clinical benefit
time frame: Week 16

Secondary Outcomes

Measure
Overall Response of PR or Greater
time frame: baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months
Progression-Free Survival
time frame: Every 8 Weeks until death, assessed up to 24 months
Duration of Response
time frame: baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months
Overall Survival
time frame: every 8 weeks until death, assessed up to 36 months
Safety and Tolerability
time frame: more than 30 days after the last date of study treatment, assessed up to 24 months

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

Inclusion Criteria: - Patient has a confirmed diagnosis of a solid tumor or hematological malignancy with the exception of endometrial cancer, glioblastoma, nonsmall cell lung cancer, prostate cancer or breast cancer. - Patient's tumor has been evaluated and pre-identified to have activation of the PI3K pathway, at a CLIA certified laboratory - Patient must have received at least one prior treatment for recurrent metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission. - Patient must have progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines - Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 Exclusion Criteria: Patient has received previous treatment with BKM120 Patient has symptomatic CNS metastases Patient has mood disorder as outlined in Section 5 Patient has received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug.

Additional Information

Official title Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 1 - BKM120 for Patients With PI3K-activated Tumors
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Novartis.